Manager, Data Integrity Monza

Manager, Data Integrity
Monza
Lombardia, Monza

Joining the Quality Function, you will coordinate and facilitate cross-functional groups within Quality Operations on Data Integrity topics

This position will be responsible for:

- Ensuring operations operates under applicable regulatory policies in respect to data integrity/guidelines as well as striving for continuous improvement;

The position represents the Data Integrity Compliance Officer and he/she is the point person during regulatory audits for Data Integrity and plays a major role in regulatory and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place for Patheon to maintain its license to operate

**ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES**:

- Establishes and chairs the site Data Integrity Governance Team meetings.

- Ensures all the new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.

- Ensures that assessments are update to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity.

- Ensures Governance Team deliverables are on target, properly resourced and executed as committed.

- Communicates actions, compliance gaps, and commitments to respective areas, including the Quality Director.

- Supervises risk assessments to determine high risk equipment and audit trails and set guidelines and rules to bring into compliance.

- Facilitates discussion with vendors and relevant functions about software capabilities in regards to 21CFR Part 11 compliance.

- Ensures that DI expertize is always represented during self-audit for all GMP areas;

- Directs immediate reports and DI Governance team in setting priorities and project assignments.

- Ensures that technical responses to questions/issues raised by regulatory agencies and customers are always provided.

- Collaborates on projects to meet customer, business, and regulatory requirements for Data Integrity

- Ensures the control and coordination of the team through the definition of objectives, the periodic review of the performance, the analysis of needs to ensure their development and to guarantee a high level of performance and motivation.

**Education

- Bachelor's Degree in Science, Engineering, or related fields

**Technical Skills

- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).

- Experience 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.

- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

**Professional Background

- Must have at least 7 years experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.

- Project Management, Supervision or Management experience are preferred.

**Languages

- English, fluent

**Personality Traits

- Leadership, including change management

- Team work

- Listening, negotiation and communication skills

- Strategic thinking

Pragmatic and oriented to prioritization and results achievement